BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION PEN NEEDLE

    MDR report key: 11572128 · Received March 25, 2021

    Report

    Report Number
    2243072-2021-00874
    Event Type
    Malfunction
    Date Received
    March 25, 2021
    Date of Event
    March 1, 2021
    Report Date
    June 17, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
    Product Code
    FMI
    PMA / PMN Number
    K162516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF PN RELION 32G X 4MM 3B TW 50CT WERE UNABLE TO DELIVER MEDICATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: " IT WAS REPORTED, PEN NEEDLES DO NOT ATTACH, PEN NEEDLE DISATTACHED FROM INSULIN PEN WHEN TAKING INJECTION. VERBATIM: PER US COM UPDATE IN SNOW: UNSUCCESSFUL CUSTOMER CONTACT AT 2021-03-02 17:07:46. RECEIVED VOICEMAIL FROM WALGREENS CONSUMER STATING "PEN NEEDLES DO NOT ATTACH" STATED, "PEN NEEDLE DISATTACHED FROM INSULIN PEN WHEN TAKING INJECTION" STATED, THE BOX IS "A DIFFERENT COLOR" REQUESTED CALL BACK. CL" D.1. MEDICAL DEVICE BRAND NAME: RELION® PEN NEEDLE D.3. MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU (SUZHOU) D.4. MEDICAL DEVICE LOT#: 320618. D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). G.1. MANUFACTURING LOCATION: BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU (SUZHOU) G.5. PMA / 510(K)#: K162516 H.6. INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. DHR COULD NOT BE PERFORMED DUE TO UNKNOWN LOT#.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. DUE TO BATCH BEING UNKNOWN, NO DHR CAN BE COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF RELION® PEN NEEDLE WERE UNABLE TO DELIVER MEDICATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: " IT WAS REPORTED, PEN NEEDLES DO NOT ATTACH, PEN NEEDLE DISATTACHED FROM INSULIN PEN WHEN TAKING INJECTION. VERBATIM: PER US COM UPDATE IN SNOW: UNSUCCESSFUL CUSTOMER CONTACT AT 2021-03-02 17:07:46. RECEIVED VOICEMAIL FROM WALGREENS CONSUMER STATING "PEN NEEDLES DO NOT ATTACH". STATED, "PEN NEEDLE DISATTACHED FROM INSULIN PEN WHEN TAKING INJECTION". STATED, THE BOX IS "A DIFFERENT COLOR". REQUESTED CALL BACK. CL".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF UNSPECIFIED BD PEN NEEDLE WERE UNABLE TO DELIVER MEDICATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: " IT WAS REPORTED, PEN NEEDLES DO NOT ATTACH, PEN NEEDLE DISATTACHED FROM INSULIN PEN WHEN TAKING INJECTION. VERBATIM: PER US COM UPDATE IN SNOW: UNSUCCESSFUL CUSTOMER CONTACT AT 2021-03-02 17:07:46. RECEIVED VOICEMAIL FROM WALGREENS CONSUMER STATING "PEN NEEDLES DO NOT ATTACH" STATED, "PEN NEEDLE DISATTACHED FROM INSULIN PEN WHEN TAKING INJECTION." STATED, THE BOX IS "A DIFFERENT COLOR." REQUESTED CALL BACK."

    Additional Manufacturer Narrative · 1

    "UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF UNSPECIFIED BD PEN NEEDLE WERE UNABLE TO DELIVER MEDICATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: " IT WAS REPORTED, PEN NEEDLES DO NOT ATTACH, PEN NEEDLE DISATTACHED FROM INSULIN PEN WHEN TAKING INJECTION. VERBATIM: PER US COM UPDATE IN (B)(4): UNSUCCESSFUL CUSTOMER CONTACT AT (B)(6) 2021, 17:07:46. RECEIVED VOICEMAIL FROM (B)(6) CONSUMER STATING "PEN NEEDLES DO NOT ATTACH." STATED, "PEN NEEDLE DISATTACHED FROM INSULIN PEN WHEN TAKING INJECTION." STATED, THE BOX IS "A DIFFERENT COLOR." REQUESTED CALL BACK. (B)(4)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467852 RELION PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1